A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 26998
- Locations
- 2
- Primary Endpoint
- Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.
This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.
Detailed Description
Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill. Secondary Objectives: * Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients. * Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meet the Medicare criteria for lung cancer screening, as updated in February 2022:
- •Age 50 - 77 years
- •Smoked at least 20 pack years
- •Current smoker or quit smoking within the past 15 years
- •Be scheduled to see a primary care provider within the health network in the next 3-4 weeks
- •Have a patient portal account or cellphone number listed in the electronic health record
Exclusion Criteria
- •Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).
- •Those for whom lung cancer screening would be inappropriate:
- •Prior history of lung cancer
- •Chest CT within the last 12 months
- •Those with medical conditions predicting shorter life expectancy
- •Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)
Outcomes
Primary Outcomes
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
Time Frame: Within 16 weeks of enrollment
Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review
Secondary Outcomes
- Proportion of Patients With LCS Scans Ordered(16 weeks)
- LCS Screening Decision(Up to 16 weeks after day of enrollment)
- Proportion of Patients With LCS Clinic Visits Scheduled(16 weeks)
- Proportion of Patients With LCS Clinic Visits Completed(16 weeks)
- LCS Clinic Referral Requested Through mPATH(16 weeks)
- Lung Cancer Screening Test Results(16 weeks)
- Number of LCS False Positives(1 year)
- Invasive Procedures Following LCS Scan(1 year)
- Proportion of Patients With Complications Following LCS(1 year)
- Number of Diagnosed Lung Cancers(16 months after randomization)
- How Diagnosed Lung Cancers Were Detected(16 months after randomization)
- Stage of Lung Cancers Diagnosed(16 months after randomization)
- Overscreening(1 year)
- Reach of Digital Outreach Strategy(16 weeks)
- Completion of mPATH-Lung Program(16 weeks)